Bioequivalence of a novel high-dose oral formulation of α-dihydroergocryptine

Arzneimittel-Forschung/Drug Research

Volumn 56, Issue 3, 2006, Pages 205-211

  De Mey, Christian ^a   Stamenova, Paraskeva ^b   Daskalov, Marin ^b   Orozova, Milka ^b   Staikov, Ivan ^b   Vlahov, Vitan ^b   Wangemann, Martina ^c  

^a ACPS Applied Clinical Pharmacology Services   (Germany)

^b MHAPT Zaritza Johanna ^*  (Bulgaria)

^c ALK SCHERAX Arzneimittel GmbH   (Germany)

Author keywords

Almirid 20 mg tablet, bioequivalence study; Almirid 40 mg tablet, bioequivalence study; CAS 14271 05 7; Dopaminergic agonist; Parkinson disease; Dihydroergocryptine, pharmacokinetics

Indexed keywords

DIHYDROERGOCRYPTINE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GEOMETRY; HUMAN; IN VIVO STUDY; MALE; PARKINSON DISEASE; RANDOMIZED CONTROLLED TRIAL;

EID: 33645467692     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296712     Document Type: Article

References (13)

1. Althaus, M., Retzow, A., Castell, J. et al., In vitro identification of the cytochrome P-450 isoenzyme responsible for the metabolism of α-dihydroergocryptine. Xenobiotica 2000; 30: 1033-45
2. Mas-Chamberlin, C., Bromet, N., Olgiati, V. et al., Metabolism study of dihydro-α-ergocryptine,9,10-[9,10-3H(N)] in rat and human hepatocyte cultures and rat, monkey, and human microsomes. American Journal of Therapeutics 1997; 4: 291-297
3. Ronca, F., Guazzelli, M., Salvadori, P. et al., Pharmacokinetic and metabolism study in healthy volunteers after administration of single oral dose of 3H-α-dihydroergocryptine mesylate. American Journal of Therapeutics 1996; 3: 553-562
4. de Mey, C., Althaus, M., Ezan, E. et al., Erythromycin increases plasma concentrations of α-dihydroergocryptine in man. Clin. Pharmacol. Ther. 2001; 70(2): 142-8
5. de Mey, C., Sulowicz, W., Stompór, T. et al., Pharmacokinetics of a single dose of α-dihydroergocryptine in patients with moderate to severe renal insufficiency, Arzneim.-Forsch./Drug Res. 2003; 53(11): 769-73
6. Althaus, M., de Mey, C., Ezan, E. et al., Plasma and urine pharmacokinetics of the dopamine agonist α-dihydroergocryptine in patients with hepatic dysfunction. Int. J. Clin. Pharmacol. Ther. 2001; 39: 67-74
7. Mine, D., Varga, I., Falup-Pecurariu, C. et al., Influence of the dopamine agonist alpha-dihydroergocryptine on the pharmacokinetics of levodopa in patients with Parkinson's disease. Clin. Neuropharmacol. 2001; 24: 235-238
8. Retzow, A., Althaus, M., de Mey, C. et al., Study on the interaction of the dopamine agonist α-dihydroergocryptine withn the pharmacokinetics of digoxin. Arzneim. Forsch./Drug Res. 2000; 50: 591-596
9. Cawello, W. (ed.), Parameters for compartment-free pharmacokinetics. Standardisation of study design, data analysis and reporting. Shaker Verlag, Aachen (1999)
10. Hauschke, D., Steinijans, V. W., Diletti, E., A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 1992; 30 Suppl 1: S37-43
11. Schwab, R. S., England, A. C., Projection technique for evaluating surgery in Parkinson's disease. In: Third symposium on Parkinson's disease, Eds Gillingham F. J. et al., E. S. Livingston, Edinburgh (1969)
12. Hoehn, M. M., Yahr, M. D., Parkinsonism: onset, progression, and mortality. Neurology 1967; 17: 427-442
13. Fahn, S., Marsden, C. D., Goldstein, M., Unified Parkinson's disease rating scale. In: Recent developments in Parkinson's disease II, S. Fahn et al. (eds.), pp. 153-163, Macmillan, New York (1987)